Sanofi Medical Regulatory Writer Role For MSc & PhD – Apply Now!
Senior Medical Regulatory Writer
Location: Hyderabad
Time Type: Full-time
Posted On: Posted Yesterday
Time Left to Apply: End Date: February 28, 2025 (30+ days left to apply)
Job Requisition ID: R2746373
About the Job
Our Team:
Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
Main Responsibilities:
- Write and/or edit high-quality safety and clinical documents, including:
- Medical sections of Periodic Benefit-Risk Evaluation Reports
- Medical sections of Addendum to clinical overviews
- Clinical Study Reports (CSR)
- Disease and product ID Cards
- Clinical evaluation reports, product alerts, and trial transparency documents
- Deliver high-quality medical documents on time and in compliance with internal and external standards and guidelines.
- Work independently on documents with minimal supervision, and act as a mentor to medical writers, efficiently peer reviewing their work.
Essential Job Duties and Responsibilities:
- Participate independently in the planning of analysis and data presentation , initially in conjunction with the mentoring medical writer.
- Develop and maintain Therapeutic Area (TA) expertise.
- Review content created by peer writers.
- Collaborate effectively with:
- Scientific communication teams (global or local)
- Medical regulatory writing teams (global or local)
- Pharmacovigilance teams
- Regulatory and Corporate Affairs Teams
People:
- Maintain effective relationships with stakeholders (Medical scientific community) within the allocated Global business unit and product to develop medical regulatory content as per requirement.
- Interact effectively with stakeholders in medical and pharmacovigilance departments.
- Assist other medical regulatory writers in developing knowledge and sharing expertise.
Performance:
- Provide deliverables as per agreed timelines and quality, including:
- PBRER
- ACO
- CSR
- Product and Disease ID Cards
- Clinical evaluation report
- Briefing packages
- Medical section of CTA
- Managing Product Alerts
- Posting trial information (study protocol, amendments, study results, redacted documents, lay summaries) on websites such as CTG (ct.gov), EUCTR, EUDRACT.
Process:
- Author, review, and act as an expert in the field of medical regulatory writing, ensuring compliance with regulatory requirements for countries supported.
- Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
- Implement relevant elements of the medical regulatory plan and associated activities for the region.
- Work with selected vendors to deliver the required deliverables.
- Design an overall plan of action based on end-customers’ feedback to improve course content and delivery.
- Prepare/review stand-by statements and questions and answers (SBS QA) documents for managing Product Alerts.
- Track postings, file, or archive material in relevant systems, ensuring audit and inspection-readiness.
- Stay updated with Sanofi Policy or Quality Documents evolution.
Stakeholders:
- Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
- Proactively liaise with Clinical/Medical/Pharmacovigilance/Biostatistics/Regulatory/Legal/Corporate Affairs departments to prepare relevant and customized deliverables.
About You
Experience: Over 5 years of experience in regulatory writing for the pharmaceutical/ healthcare industry.
Soft Skills:
- Stakeholder management
- Vendor management
- Communication skills
- Ability to work independently and within a team environment
Technical Skills:
- Medical operational excellence
- Time and risk management skills
- Excellent technical (medical) editing and writing skills
- Data retrieval and interpretation of scientific data
- Medical literature screening
- Knowledge of ICH and GCP/GVP
- Ability to summarize scientific information and edit text for specific audiences
- Proficiency with computer applications
Education:
- Advanced degree in life sciences/pharmacy/similar discipline (PhD, Masters, Bachelor’s in Science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD).
Languages:
- Excellent knowledge of the English language (to read, write, and speak).
Keywords: Senior Medical Regulatory Writer, Sanofi Global Hub, Hyderabad, Regulatory Writing, Pharmaceutical Industry, Healthcare, Stakeholder Management, Medical Document Editing. Sanofi Medical Regulatory Writer Role For MSc & PhD – Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
